MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 PROX. HUM.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-2035
Medical Device Problem Codes	Crack (1135); Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported, the distal locking hole of the proximal humeral nail targeting arm was broken.This caused the drill bit to miss the most distal locking hole in the nail.
Additional Manufacturer Narrative
The reported event that targeting arm t2 prox.Hum.Was alleged of instrument - mis-drilling could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instruction for ¿cleaning, sterilization, inspection and maintenance¿ should be considered to check instruments.As nothing was reported during pre-operative check which is required per ifu the case is rather related to a sub-optimal intraoperative procedure which has to be considered as user related.Nevertheless, more detailed information about the complaint event as well as the affected device must be available in order to determine an exact root cause of the complaint event.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
Event or Problem Description
It was reported, the distal locking hole of the proximal humeral nail targeting arm was broken.This caused the drill bit to miss the most distal locking hole in the nail.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10015524
• Report Number: 0009610622-2020-00184
• Device Sequence Number: 14195262
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1806-2035
• Device Catalogue Number: 18062035
• Device Lot Number: KP218578/KH10277
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR